Regulatory Affairs Officer

BUEN BIOCEUTICALS supplies a variety of health food and health supplement brands from New Zealand. As a Regulatory Affairs Officer, you will be responsible for the regulatory compliance of health supplements, nutritional products, and related materials. You will ensure all products meet regulatory requirements for import, registration, and marketing, while managing documentation, approvals, and communication with relevant authorities to support smooth and timely market entry.
Key Responsibilities:
- Be familiar and keep up to date with regulatory requirements for product registration, import, and marketing claims of therapeutic products, nutritional products, and related materials.
- Research and conduct product claim development and prepare claim documentation for product registration.
- Obtain, monitor, and maintain product registration and relevant authorities' approval for therapeutic products, nutritional products, and related materials.
- Ensure effective management of declarations and regulatory approvals to meet company and regulatory requirements.
- Prepare, compile, maintain, and review documentation related to product registration and regulatory compliance in a timely manner.
- Handle any enquiries from regulatory bodies regarding product registration and regulatory compliance discretion.
- Pre-screen products and materials, and provide regulatory feedback to the team to ensure smooth product registration.
- Verify the company's conformance with regulatory standards.
- Understand aspects of product development, including clinical trials, research, manufacturing practices, regulations, and authorities' approval processes in different markets.
- Strategize to achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, compliance, and technology.